Perforator Handpiece 1700761-001

GUDID 17630055506518

Bien-Air Surgery SA

Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable Manual cranial rotary handpiece, reusable

• Primary Device ID: 17630055506518
• NIH Device Record Key: abb0a426-737d-4f49-8d42-118cb08dd594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perforator Handpiece
• Version Model Number: 362640
• Catalog Number: 1700761-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17630055506518 [Primary]

FDA Product Code

• HBC: Motor, Drill, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-27
• Device Publish Date: 2023-03-17

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• 27630055515784 - Bur PM2-70 80K diam Ø1.4 St: 2024-04-09
• 27630055515791 - Bur PM2-70 80K diam Ø1.8 St: 2024-04-09
• 27630055515807 - Bur PM2-70 80K diam Ø2.3 St: 2024-04-09